Findings Support Advancement of PRTX-100 into its Third Clinical
Indication

June 12, 2018 08:00 AM Eastern Daylight Time

FLORHAM PARK, N.J.--(BUSINESS WIRE)--Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical
company, today announced preliminary findings that its lead drug
candidate PRTX-100 reduced disease activity in a second, confirmatory
mouse study of myasthenia gravis (MG), an autoimmune disorder mediated
by anti-self antibodies that react with the neuromuscular junction. The
study was conducted by the Laboratory for Myasthenia Gravis Research at
George Washington University.

The study demonstrated potential clinical benefits of PRTX-100 in mice
with established MG symptoms. Treatment with PRTX-100 preserved grip
strength and decreased disease activity scores relative to control
animals.

“We are encouraged by the data readout on our second confirmatory
preclinical study for PRTX-100 in MG and hope to use it to advance our
path to clinical development in this indication,” said Michelle D.
Catalina, Ph.D., Preclinical Director of Protalex. “Autoimmune disorders
typically have great impact on quality of life for patients, and often
have few effective and tolerable treatment options. It is our hope to
advance PRTX-100 in MG, with the goal of offering a new treatment
option. We expect a detailed analysis of the final study results will be
presented for scientific presentation later this summer and subsequently
for publication.”

About Myasthenia Gravis

MG is an autoimmune disorder caused by anti-self antibodies that react
with the neuromuscular junction, causing muscle weakness
and fatigability. MG remains underdiagnosed in the U.S. and has an
estimated incidence of 14 to 20 per 100,000 population, meaning there
are approximately 36,000 to 60,000 cases in the U.S.1 Current
treatments, which include corticosteroids and immunosuppressant agents,
are not optimal as they can cause severe adverse events. Neurological
autoimmune disorders in general lack efficacious treatments without
adverse side effects.

About PRTX-100

PRTX-100, a new-generation immunomodulatory therapy, is a highly
purified form of SpA, an immunomodulatory protein known to modify
aspects of the human immune system. PRTX-100 has the ability, at very
low concentrations, to bind to human B-lymphocytes and macrophages and
to modulate immune processes. The safety, tolerability and
pharmacokinetics of PRTX-100 have been characterized in eight human
clinical studies (seven completed, one ongoing), and PRTX-100 has been
granted Orphan Drug Designation in the U.S. and Europe for the treatment
of Immune Thrombocytopenia (ITP). In two Phase 1b clinical trials in
adult patients with active Rheumatoid Arthritis (RA), PRTX-100 was
generally safe and well tolerated at all dose levels, and at certain
higher doses, more patients showed improvement in measures of RA disease
activity than did patients at the lower dose or placebo cohorts.
PRTX-100 is given as a short intravenous infusion.

About Protalex, Inc.

Protalex, Inc. is a clinical-stage biopharmaceutical company focused on
the development of a class of drugs for treating autoimmune and
inflammatory diseases including RA and ITP. In the U.S., Protalex has
open INDs for the treatment of RA and ITP and in Europe, an open IMPD
for ITP. Please visit the Protalex website at www.protalex.com
to learn more about Protalex and its lead drug candidate, PRTX-100.

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